10734099

System, Method, and Apparatus for Documenting and Managing Biopsy Specimens and Patient-specific Information On-site

PublishedAugust 4, 2020
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Technical Abstract

Patent Claims
11 claims

Legal claims defining the scope of protection. Each claim is shown in both the original legal language and a plain English translation.

Claim 1

Original Legal Text

1. A method for documenting and managing biopsy or procedure associated data at the place and time of biopsy specimen collection, and the method comprising the steps of: retrieving patient information directly through a specimen information system; communicating a patient name, a procedure type, and a site of the biopsy, to a user at the time and place of collection of the biopsy specimen; receiving confirmations from the user through the specimen information system of the name of the patient, the biopsy specimen type, and the site of the biopsy; associating the biopsy specimen with a uniquely identified specimen container securing the biopsy in response to receiving the confirmations; prior to fixation of the biopsy specimen and prior to transporting the biopsy specimen to a laboratory for processing, capturing one or more images of the biopsy specimen container with a digital imaging device at the time and place of collection of the biopsy specimen to provide the one or more images of the biopsy specimen in a pre-processed state; performing, with a computer, image analysis and biopsy area measurements utilizing the one or more images of the biopsy specimen captured prior to fixation and prior to transporting the biopsy specimen to the laboratory; providing one or more differential diagnoses related to the biopsy specimen, based at least in part on the one or more images captured prior to fixation and prior to transporting the biopsy specimen to the laboratory, with the computer; and linking specimen information, including at least the captured one or more images, image analysis, and biopsy area measurements, and the patient information in the system, wherein: the linking is performed at the time and location a biopsy is performed to document what biopsy specimen was collected from the patient; and the specimen information and the patient information are available in the system for access by laboratory personnel.

Plain English Translation

A system and method for on-site biopsy management at the time of specimen collection. It retrieves patient information directly, communicates patient name, procedure type, and biopsy site to a user, and receives confirmations for these details. The system then associates the biopsy specimen with a uniquely identified container. Crucially, before the specimen is fixed or sent to a lab, it captures images of the container with a digital imaging device at the collection site. A computer performs image analysis and measures the biopsy area using these pre-processed images. The system also generates differential diagnoses based on these early images. Finally, it links all specimen information (images, analysis, measurements) with patient information directly at the biopsy location, making it accessible to laboratory personnel.

Claim 2

Original Legal Text

2. The method according to claim 1 , wherein the confirmations are received one at a time.

Plain English Translation

This method enhances on-site biopsy management by retrieving patient information directly and displaying patient name, procedure type, and biopsy site to a user at the collection location. The system receives confirmations for these details, specifically one at a time, before associating the biopsy specimen with a unique container. Prior to fixation or transport to a lab, it captures images of the container with a digital imaging device. A computer then analyzes these pre-processed images, measures biopsy areas, and provides differential diagnoses. All specimen data (images, analysis, measurements) and patient information are linked immediately at the biopsy site, ensuring lab personnel have access.

Claim 3

Original Legal Text

3. The method according to claim 1 , wherein the container is a tissue cassette.

Plain English Translation

This on-site biopsy management method retrieves patient data, displays the patient's name, procedure type, and biopsy site to a user, and receives confirmations for these details. The system then associates the biopsy specimen with a uniquely identified tissue cassette. Crucially, before the specimen is fixed or transported to a lab, it captures images of this tissue cassette using a digital imaging device at the collection site. A computer analyzes these pre-processed images to measure the biopsy area and generate differential diagnoses. All specimen information (images, analysis, measurements) and patient information are linked immediately at the biopsy location, making it accessible to laboratory personnel.

Claim 4

Original Legal Text

4. The method according to claim 1 , further comprising the step of: applying an identifier to the container.

Plain English Translation

This on-site biopsy management method retrieves patient data, displays the patient's name, procedure type, and biopsy site to a user, and receives confirmations for these details. The system then applies a unique identifier to the specimen container and associates the biopsy specimen with this uniquely identified container. Crucially, before the specimen is fixed or transported to a lab, it captures images of the container using a digital imaging device at the collection site. A computer analyzes these pre-processed images to measure the biopsy area and generate differential diagnoses. All specimen information (images, analysis, measurements) and patient information are linked immediately at the biopsy location, making it accessible to laboratory personnel.

Claim 5

Original Legal Text

5. The method according to claim 4 , further comprising the step of: storing the patient information, the identifier, and the specimen information in a database accessible through one or more networks by the specimen information system.

Plain English Translation

This on-site biopsy management method retrieves patient data, displays the patient's name, procedure type, and biopsy site to a user, and receives confirmations for these details. The system then applies a unique identifier to the specimen container and associates the biopsy specimen with this container. It stores the patient information, the container identifier, and all specimen information in a network-accessible database. Crucially, before the specimen is fixed or transported to a lab, it captures images of the container using a digital imaging device at the collection site. A computer analyzes these pre-processed images to measure the biopsy area and generate differential diagnoses. All specimen information (images, analysis, measurements) and patient information are linked immediately at the biopsy location, making it accessible to laboratory personnel through the system.

Claim 6

Original Legal Text

6. The method according to claim 1 , further comprising the steps of: scanning notes or other clinical information associated with the biopsy specimen into the specimen information system; and associating the notes with biopsy/procedure information.

Plain English Translation

This on-site biopsy management method retrieves patient data, displays the patient's name, procedure type, and biopsy site to a user, and receives confirmations for these details. The system then associates the biopsy specimen with a uniquely identified container. It also scans clinical notes or other relevant information into the system and associates these notes with the biopsy data. Crucially, before the specimen is fixed or transported to a lab, it captures images of the container using a digital imaging device at the collection site. A computer analyzes these pre-processed images to measure the biopsy area and generate differential diagnoses. All specimen information (images, analysis, measurements, and associated notes) and patient information are linked immediately at the biopsy location, making it accessible to laboratory personnel.

Claim 7

Original Legal Text

7. The method according to claim 1 , further comprising the step of: associating one or more additional images with the specimen information.

Plain English Translation

This on-site biopsy management method retrieves patient data, displays the patient's name, procedure type, and biopsy site to a user, and receives confirmations for these details. The system then associates the biopsy specimen with a uniquely identified container. It also associates one or more additional images with the specimen information. Crucially, before the specimen is fixed or transported to a lab, it captures initial images of the container using a digital imaging device at the collection site. A computer analyzes these pre-processed initial images to measure the biopsy area and generate differential diagnoses. All specimen information (initial and additional images, analysis, measurements) and patient information are linked immediately at the biopsy location, making it accessible to laboratory personnel.

Claim 8

Original Legal Text

8. The method according to claim 1 , wherein user input to the specimen information system is received through a wireless device.

Plain English Translation

This on-site biopsy management method retrieves patient data, displays the patient's name, procedure type, and biopsy site to a user, and receives user input, including confirmations for these details, via a wireless device. The system then associates the biopsy specimen with a uniquely identified container. Crucially, before the specimen is fixed or transported to a lab, it captures images of the container using a digital imaging device at the collection site. A computer analyzes these pre-processed images to measure the biopsy area and generate differential diagnoses. All specimen information (images, analysis, measurements) and patient information are linked immediately at the biopsy location, making it accessible to laboratory personnel.

Claim 9

Original Legal Text

9. The method according to claim 1 , wherein the specimen information system implements a software application for managing the patient information and the physical tissue characteristics taken at the time and location of the procedure.

Plain English Translation

This on-site biopsy management method, implemented via a software application, retrieves patient data and manages patient information alongside physical tissue characteristics captured at the procedure location. It displays the patient's name, procedure type, and biopsy site to a user, receiving confirmations for these details. The system then associates the biopsy specimen with a uniquely identified container. Crucially, before the specimen is fixed or transported to a lab, it captures images of the container with a digital imaging device at the collection site. A computer analyzes these pre-processed images to measure the biopsy area and generate differential diagnoses. All specimen information (images, analysis, measurements) and patient information are linked immediately at the biopsy location, making it accessible to laboratory personnel.

Claim 10

Original Legal Text

10. The method according to claim 1 , further comprising the step of: shipping the specimen container to a pathologist for analysis, wherein the pathologist may access any of the name of the patient, the biopsy specimen type, the site of the biopsy, the captured one or more images, and the one or more differential diagnoses from the specimen information system.

Plain English Translation

This on-site biopsy management method retrieves patient data, displays the patient's name, procedure type, and biopsy site to a user, and receives confirmations for these details. The system then associates the biopsy specimen with a uniquely identified container. Crucially, before the specimen is fixed or transported to a lab, it captures images of the container using a digital imaging device at the collection site. A computer analyzes these pre-processed images to measure the biopsy area and generate differential diagnoses. All specimen information (images, analysis, measurements) and patient information are linked immediately at the biopsy location. The system also supports shipping the specimen container to a pathologist, who can then access patient name, biopsy type, site, captured images, and differential diagnoses directly from the system for analysis.

Claim 11

Original Legal Text

11. The method of claim 1 , wherein capturing one or more images of the biopsy specimen container with the digital imaging device comprises rapidly and sequentially placing tissue processing cassettes under a camera or scanner for immediate registration by an electronic reading device.

Plain English Translation

This on-site biopsy management method retrieves patient data, displays the patient's name, procedure type, and biopsy site to a user, and receives confirmations for these details. The system then associates the biopsy specimen with a uniquely identified container. Crucially, before the specimen is fixed or transported to a lab, it captures images of the container by rapidly and sequentially placing tissue processing cassettes under a camera or scanner for immediate electronic registration at the collection site. A computer then analyzes these pre-processed images to measure the biopsy area and generate differential diagnoses. All specimen information (images, analysis, measurements) and patient information are linked immediately at the biopsy location, making it accessible to laboratory personnel.

Patent Metadata

Filing Date

Unknown

Publication Date

August 4, 2020

Inventors

Mark S. Evans
Matthew O. Leavitt
Jared L. Szymanski
Michael Andrew Ivie
Derek Brett Mann

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